FDA accepts Otsuka's app for long-lasting Abilify

Otsuka Pharmaceutical has taken an important step forward in the development of a once-monthly version of its blockbuster schizophrenia drug Abilify (aripiprazole). U.S. regulators have accepted for review the company's application for marketing approval of the controlled-release drug, the company's partner for the product, Lundbeck, announced Tuesday.

The product, called aripiprazole depot formulation, was one of the key assets featured in the global collaboration pact between Copenhagen-based Lundbeck and Otsuka revealed on Nov. 11. It would drastically reduce the number of times per month that a patient has to take the drug, which brought in $4.5 billion in 2010, and that could improve how well a patient sticks to doctors' orders for taking the treatment. Otsuka currently markets a once-daily tablet form of Abilify and an injectable version in partnership with Bristol-Myers Squibb ($BMS).

Otsuka and Lundbeck might have some competition for their once-monthly Abilify. Dublin-based drugmaker Alkermes ($ALKS) has its own version of the drug that calls for monthly injections, ALKS 9070, which has completed Phase II clinical trials. There are differences between 9070 and Otsuka's aripiprazole depot. For instance, Otsuka's aripiprazole depot formulation comes in a freeze-dried cake, to which water is added before it can be injected into patients, whereas Alkermes' treatment doesn't require a water-mixing step.

Cowen and Company analysts wrote in a note to investors earlier this month that "we would highlight that ALKS-9070 might have some modest advantages over its competitor as it is a suspension whereas Otsuka's product needs to be reconstituted. Alkermes has received clearance from the FDA for initiating its Phase III program, which we believe should take approximately a year and a half, putting it on target for approval ahead of the expiration of the Abilify patent in 2015."

- here's Lundbeck's release
- see Reuters' coverage

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